Clinical Trials Register

Summary
EudraCT Number:	2013-000476-14
Sponsor's Protocol Code Number:	TCI_BRIVA
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-03-19
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Sweden - MPA

A.2

EudraCT number

2013-000476-14

A.3

Full title of the trial

TARGET-CONTROLLED INFUSION (TCI) WITH PROPOFOL AND REMIFENTANIL AS ANALGO-SEDATION IN WOUND CARE IN PATIENTS WITH BURNS

MÅL-KONTROLLERAD INFUSION (TCI) MED PROPOFOL OCH REMIFENTANIL SOM ANALGO-SEDERING UNDER SÅRVÅRD HOS PATIENTER MED BRÄNNSKADA

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

TARGET-CONTROLLED INFUSION (TCI) WITH PROPOFOL AND REMIFENTANIL AS ANALGO-SEDATION IN WOUND CARE IN PEOPLE WITH BURNS

MÅL-KONTROLLERAD INFUSION (TCI) MED PROPOFOL OCH REMIFENTANIL SOM ANALGO-SEDERING UNDER SÅRVÅRD HOS PERSONER MED BRÄNNSKADA

A.3.2

Name or abbreviated title of the trial where available

TCI BRIVA

A.4.1

Sponsor's protocol code number

TCI_BRIVA

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	LANDSTINGET I ÖSTERGÖTLAND
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	LIO SINNESCENTRUM
B.4.2	Country	Sweden
B.4.1	Name of organisation providing support	STEN-OTTO LILJEDAHLS FOND
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	LANDSTINGET I ÖSTERGÖTLAND
B.5.2	Functional name of contact point	UNIVERSITETSSJUKHUSET I LINKÖPING
B.5.3	Address:
B.5.3.1	Street Address	UNIVERSITETSSJUKHUSET I LINKÖPING
B.5.3.2	Town/ city	LINKÖPING
B.5.3.3	Post code	58185
B.5.3.4	Country	Sweden
B.5.4	Telephone number	+46010103 18 20
B.5.6	E-mail	folke.sjoberg@lio.se

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Remifentanil
D.3.9.1	CAS number	132875-61-7
D.3.9.3	Other descriptive name	REMIFENTANIL HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04215MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1 to 5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fentanyl
D.3.9.1	CAS number	990-73-8
D.3.9.3	Other descriptive name	FENTANYL CITRATE
D.3.9.4	EV Substance Code	SUB02129MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Burn patients who need analgo-sedation during wound care.

Patienter med brännskada som behöver analgo-sedering under sårvård.

E.1.1.1

Medical condition in easily understood language

Burn patients who need pain relief and sedation during wound care

Patienter med brännskada som behöver smärtlindring och sedering under sårvård.

E.1.1.2

Therapeutic area

Health Care [N] - Health Care Facilities, Manpower, and Services [N02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10028175
E.1.2	Term	Multiple burns
E.1.2	System Organ Class	100000004863

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate whether Target-Controlled infusion (TCI) with propofol and remifentanil can be used as analgo-sedation on burn patients and if the method can shorten the recovery time after wound care compared with daily routine of continous infusion of propofol with intermittent bolus of fentanyl.

Att utvärdera om Mål-kontrollerad infusion (TCI) med propofol och remifentanil kan användas vid analgo-sedering av brännskadade patienter och om metoden kan bidra till att förkorta tiden för återhämtning efter sårvård jämfört med en rutinmässig användning av kontinuerlig infusion av propofol och intermittenta bolusdoser med fentanyl.

E.2.2

Secondary objectives of the trial

To evaluate whether Target-Controlled infusion (TCI) of propofol and remifentanil compared with routine use of continuous infusion of propofol and intermittent bolus doses of fentanyl can shorten the time until mobilisation and nutrition. Measurement of the total energy intake during the day for wound care are implemented as well the number of adverse events and the necessary interventions as well as the total dose administered analgesia and anti-emetics. Finally, the research estimates the perceived pain and experience during wound care. The staff at ward will after the wound care evaluate the wound care conditions.

Att utvärdera om Mål-kontrollerad infusion (TCI) med propofol och remifentanil jämfört med en rutinmässig användning av kontinuerlig infusion av propofol och intermittenta bolusdoser med fentanyl kan förkorta tiden till att forskningspersonen mobilserar och nutrierar sig. Mätning av forskningspersonens totala energiintaget under dygnet för sårvården genomförs likväl antal adverse events och nödvändiga interventioner samt den totala dosen given smärtlindring och antiemetika. Slutligen skattar forskningspersonen den upplevda smärtan respektive upplevelsen under sårvården och avdelningspersonalen skattar sårvårdsbetingelserna under sårvården.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Adult patients (≥ 18 years) with burns regardless degree or extent.
The patient should be hospitalized in a swedish burn center.
The subject is planned for at least two consecutive occasions with wound care with analgo-sedation.
The patient has given their consent to participate in the study.

Vuxna patienter (≥18 år) med brännskada oavsett grad eller omfattning.
Patienten skall vara inneliggande på brännskadecenter.
Planeras att genomgå minst två på varandra efterföljande sårvårdstillfällen med analgo-sedering.
Patienten har givit sitt samtycke till att delta i studien.

E.4

Principal exclusion criteria

Patients who are ventilator treated.
Mental or physical inability, unwillingness or language difficulties that causes difficulty to understand the meaning of participation in the study, according to the responsible physician.
Wound care where bath is planned.

Contraindications to study drug:
Known or suspected allergy or hypersensitivity to oxycodone, propofol, remifentanil, morphine, selective 5-HT3 receptor antagonists, fentanyl analog, opioids, pregabalin, paracetamol, naproxen, peanuts or soy.
Respiratory depression with or without hypoxia, hypercapnia, severe bronchial asthma patients who have had symptoms of asthma, rhinitis or urticaria after taking aspirin or other anti-inflammatory agents of non-steroidal nature, severe chronic obstructive pulmonary disease and cor pulmonale.
Severe heart failure, hypovolemia and hypotension.
Increased intracranial pressure or head injury.
Myasthenia gravis.
Conditions associated with increased bleeding, an ongoing or history of gastrointestinal bleeding or perforation.
Cirrhosis of the liver.
Kidney disease (glomerular filtration rate <30 ml / min).
Paralytic ileus.
Third trimester of pregnancy and during lactation.
Concomitant use with MAO inhibitors or recent (within two weeks) discontinuation of MAO inhibitors.

Patienter som vårdas i respirator.
Mental eller fysisk oförmåga, ovilja eller språksvårigheter som medför svårighet att förstå innebörden av att delta i studien enligt inkluderande anestesiläkarens bedömning.
Sårvård där sårvårds-bad planeras.

Kontraindikationer för studieläkemedel:
Känd eller misstänkt allergi eller överkänslighet mot oxykodon, propofol, remifentanil, morfin, selektiva 5-HT3-receptorantagonister, fentanylanaloger, opioider pregabalin, paracetamol, naproxen, jordnötter eller soja.
Andningsdepression med eller utan hypoxi, hyperkapni, allvarlig bronkialastma, astmatiker som har fått symtom på astma, rinit eller urtikaria vid intag av acetylsalicylsyra eller andra antiinflammatoriska medel av icke-steroid natur, allvarlig kronisk obstruktiv lungsjukdom samt cor pulmonale.
Svår hjärtsvikt, hypovolemi och hypotension.
Förhöjt intrakraniellt tryck eller skallskador.
Myastenia gravis.
Tillstånd med ökad blödningsbenägenhet, aktiv eller anamnes på gastrointestinal blödning eller perforation.
Levercirros.
Njursjukdom (glomerulusfiltration <30 ml/min).
Paralytisk ileus.
Tredje trimestern av graviditeten och under amning.
Samtidig medicinering med MAO-hämmare eller nyligen (inom två veckor) avslutad behandling med MAO-hämmare.

E.5 End points

E.5.1

Primary end point(s)

Time to recovery after analgo-sedation.

Tid till återhämtning efter avslutad analgo-sedering.

E.5.1.1

Timepoint(s) of evaluation of this end point

0-120 minutes

0-120 minuter

E.5.2

Secondary end point(s)

Time to mobilization after analgo-sedation.
Time to nutrition post analgo-sedation.
Energy intake during the day of wound care.

During analgo-sedation:
Adverse events (AE)
interventions

Postprocedure:
Adverse events (AE)
interventions
Subjects estimation of subjective pain by using the VAS-scale
Total dose of analgesics
Total dose antiemetics

Subjects subjective experience of the wound care by using the VAS-scale.
Staffs experience of wound care conditions.

Tid till mobilisering efter avslutad analgo-sedering.
Tid till nutriering efter avslutad analgo-sedering.
Energiintag under sårvårdsdygnet.

Under analgo-sedering:
Adverse events (AE)
Interventioner

Postproceduralt:
Adverse events (AE)
Interventioner
Forskningspersonens skattning av smärta utifrån VAS
Total dos analgetika
Total dos antiemetika

Forskningspersonens upplevelse under sårvårdstillfället utifrån VAS.
Avdelningspersonalens upplevelse av sårvårdsbetingelserna under sårvården.

E.5.2.1

Timepoint(s) of evaluation of this end point

Day of analgo-sedation (24h)

Dag för analgo-sedering (24h)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-03-19.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

According to clinical pratice.

Enligt klinisk rutin.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-05-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-03-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-12-10

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